At-Home Blood Pregnancy Test Kit

ABSTRACT

Disclosed is an at-home blood pregnancy test kit that can identify the presence of hCG in a blood sample to detect pregnancy in female mammals. The present kit includes a housing having a sample strip that is in fluid communication with a sample pad for holding a blood sample, a test pad, and a conjugate pad. The housing further includes a test window and a push button for releasing a reagent that can react with hCG. The reagent and the test pad include antibodies that can bind with hCG antigens to detect presence of the same. The test window is adapted to display a symbol that indicates a negative pregnancy test result in the absence of hCG, or display a symbol that indicates a positive pregnancy test result in the presence of hCG.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.61/941,083 filed on Feb. 18, 2014. The above identified patentapplication is herein incorporated by reference in its entirety toprovide continuity of disclosure.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a pregnancy test kit. Morespecifically, the present invention pertains to a portable pregnancytest kit that is suitable for home use. The present test kit is adaptedto perform an hCG immunoassay to measure the presence of hCG in a bloodsample, thereby detecting pregnancy. If a sufficient level of hCG isdetected in the blood sample, the test kit can visually indicate thetest result.

Pregnancy tests are designed to determine whether a woman is pregnant.Most pregnancy tests are designed to indicate whether a person's urineor blood contains a hormone called human chorionic gonadotropin (hCG).This hormone is produced after a fertilized egg attaches to the wall ofa woman's uterus. In non-pregnant women, hCG levels are normallyundetectable. If a woman is pregnant, however, levels of hCG continue torise rapidly, doubling every two to three days.

Two main types of pregnancy tests are used to determine if a woman ispregnant: urine tests and blood tests. Urine tests can be done at homeor in a doctor's office. Urine tests are known to detect hCG traces aslow as 10 mlU/mL to 100 mlU/mL, and they are approximately 97 percentaccurate when performed correctly. Urine tests are widely used becausethey can be done in the privacy and convenience of a home, they give afast result, and are easy to use. However, urine tests detect apregnancy later than blood tests because urine tests are generally takenabout a week after a missed menstruation, and if done incorrectly, theresult can be inaccurate.

Blood tests are much more accurate than urine tests, and blood tests candetect a pregnancy earlier than urine tests, or only about six to eightdays after ovulation. Additionally, blood tests can measure theconcentration of hCG hormone in a woman's blood, which can be useful fortracking certain problems in pregnancy. However, blood tests take longerto produce a result, and are generally performed in a doctor's office.Thus, a blood test kit for use at home to increase the privacy andconvenience of a user is desired.

The present invention provides a blood pregnancy test kit that issuitable for home use. The present test kit comprises a qualitative hCGtest kit, which can detect presence of hCG in a blood sample of a femalemammal. The blood pregnancy test kit comprises a housing having an upperend with an opening, a lower end, a top side, a bottom side, and adefined interior volume having a sample pad, a test pad, and a conjugatepad. The opening comprises a sample strip, which extends outwardtherefrom. The sample strip is in fluid communication with the samplepad. The sample strip is adapted to absorb a blood sample and deliver itto the sample pad via capillary action or the like. Thereafter, theblood can migrate to the conjugate pad, and mix with a reagent that canbe released via a push button that is disposed on the top side of thehousing.

The reagent includes a first antibody, which can bind with any hCGantigens present in the blood when the blood and the reagent arecombined, creating a blood-reagent mixture. The mixture can then migratetoward the test pad, whereby the test pad includes a test portion and acontrol portion. The test portion includes a second antibody that islabeled, such as with dye. The dye is activated when the second antibodybinds with the hCG antigens. When the concentration of the hCG antigensin the blood exceeds a predetermined threshold, a test window disposedon the top side is adapted to show a plus sign. Conversely, the testwindow is adapted to show a minus sign if the concentration of the hCGantigens falls below the predetermined threshold. Additionally, thecontrol portion is adapted to display a symbol to visually indicate thatthe test was completed correctly, regardless of whether hCG is or is notpresent in the blood sample.

2. Description of the Prior Art

The prior art discloses a number of blood tests and various methods formeasuring hCG hormone in female mammals to detect pregnancy. Some ofthese prior art references disclose direct agglutination reagents forpregnancy testing, wherein the agglutinates indicate a positive test forpregnancy when mixed with a urine or blood sample. Other prior artreferences disclose a method for detecting pregnancy that involvesscreening a biological sample of a woman for pregnancy markers. Theprior art references, however, do not disclose a blood test kit that issuitable for home use. The foregoing is a list of prior art referencesdeemed most relevant to the present disclosure, which are hereindescribed for the purposes of highlighting and differentiating theunique aspects of the present invention, and further highlighting thedrawbacks existing in the prior art.

Specifically, U.S. Pat. No. 4,003,988 to Hoff discloses a directagglutination reagent for pregnancy testing. In one embodiment, thereagent comprises a liquid that can agglutinate when placed in contactwith bodily fluids that contain hCG and polymeric latex carrier. Thepolymeric latex carrier is coated with rabbit anti-hCG serum and thereagent is buffered to a pH of 8.6 with a buffer that comprisespiperazine dihydrochloride, water, and sodium hydroxide. Thus, Hoff doesnot disclose a blood test kit that is suitable for use at home to detectpregnancy. The present invention comprises a kit that comprises ahousing having a test window for indicating the presence of hCG, a pushbutton for releasing a reagent that react with hCG, and a sample pad forholding a blood sample.

U.S. Published Patent Application Number 2005/0148096 to Cole disclosesmethods of detecting pregnancy, wherein the methods includechemiluminescent assays for the pregnancy markers. The methods alsocomprise utilizing at least two capture antibodies that specificallybind different epitopes of the pregnancy marker in one assay.Chemiluminescence, however, must be performed in a lab, and thereforenot suitable to be performed in a home setting. Thus, Cole fails todisclose an at-home pregnancy test kit.

U.S. Pat. No. 7,666,683 to Cole discloses a method of diagnosing apregnancy, the method including the steps of measuring hyperglycosylatedhCG in a pregnant woman and comparing the concentration of measuredhyperglycosylated hCG with a predetermined value. If the measurement ofhyperglycosylated hCG is above the predetermined value, the measurementindicates a normal pregnancy, while the measurement of hyperglycosylatedhCG below the predetermined value indicates that the pregnancy isectopic. The purpose and design of the present invention, however,differ from Cole in that the present invention discloses a device fordetecting presence of hCG to determine whether the user is pregnant.Additionally, the method of Cole cannot be performed in a home setting.

U.S. Published Patent Application Number 2002/0013002 to D'Auroradiscloses a pregnancy test based on saliva or other bodily fluids. Thepregnancy kit includes a first vessel, a second vessel, and a thirdvessel, wherein the vessels are separated via removable surfaces. Thus,D'Aurora does not disclose a kit comprising a housing with a testwindow, a push button, and a sample pad, wherein the foregoingcomponents are in fluid communication with each other.

Finally, U.S. Pat. No. 4,543,339 to O'Neill discloses a method ofdetecting pregnancy in a mammal at an early stage, which comprises thestep of detecting physiological change consequent on increased activityof blood platelets resulting from the pregnancy. The enhanced activationof blood platelets is detected via: visualization with microscopy of theextent of morphological change; monitoring the release of excretedfactors, such as calcium; spectrophotometric detection of the change inoptical density of a solution containing platelets; or the determinationof the onset of membrane adhesiveness by the ability of the platelets tocause agglutination of latex particles. Thus, O'Neill does not disclosea method of detecting pregnancy, wherein the method cannot be performedin a home setting.

The methods and devices disclosed in the prior art have several knowndrawbacks. These devices and methods are limited in that they must beused or performed in a lab setting. The present invention overcomesthese limitations by disclosing an at-home blood test kit for detectingpregnancy. It is therefore submitted that the present invention issubstantially divergent in design elements from the prior art, andconsequently it is clear that there is a need in the art for animprovement to blood tests and various methods for measuring hCG hormonein female mammals. In this regard, the instant invention substantiallyfulfills these needs.

SUMMARY OF THE INVENTION

In view of the foregoing disadvantages inherent in the known types ofblood tests and various methods for measuring hCG hormone in femalemammals now present in the prior art, the present invention provides anew and improved at-home blood pregnancy test kit wherein the same canbe utilized for detecting pregnancy in female mammals in a home setting.

It is therefore an object of the invention to provide a new and improvedat-home blood pregnancy test kit that has all of the advantages of theprior art and none of the disadvantages.

Another object of the present invention is to provide a new and improvedat-home blood pregnancy test kit that comprises a housing having a testwindow for viewing the pregnancy test results and a push button forreleasing a reagent that reacts with hCG.

Yet another object of the present invention is to provide a new andimproved at-home blood pregnancy test kit having a sample pad forholding a blood sample, a conjugate pad for holding a released reagent,and a test pad for detecting and indicating the presence of hCG, whereinthe sample pad, the conjugate pad, and the test pad are in fluidcommunication.

Yet another object of the present invention is to provide a new andimproved at-home blood pregnancy test kit that can perform hCGimmunoassay using two types of antibodies and that is based on thesandwich principal.

Still yet another object of the present invention is to provide a newand improved at-home blood pregnancy test kit having a sample strip todeliver a blood sample to the sample pad.

Still yet another object of the present invention is to provide a newand improved at-home blood pregnancy test kit having a test window thatdisplays a plus sign for showing a positive pregnancy result, a minussign for showing a negative pregnancy result, and a control indicatorfor showing that the test was performed correctly.

Still yet another object of the present invention is to provide a newand improved at-home blood pregnancy test kit wherein the device may bereadily fabricated from materials that permit relative economy and arecommensurate with durability.

Other objects, features, and advantages of the present invention willbecome apparent from the following detailed description taken inconjunction with the accompanying drawings.

BRIEF DESCRIPTIONS OF THE DRAWINGS

Although the characteristic features of this invention will beparticularly pointed out in the claims, the invention itself and mannerin which it may be made and used may be better understood after a reviewof the following description, taken in connection with the accompanyingdrawings wherein the numeral annotations are provided throughout.

FIG. 1 shows a top down view of the present invention.

FIG. 2 shows a cutout view of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

References are made herein to the attached drawings. Like referencenumerals are used throughout the drawings to depict like or similarelements of the at-home blood pregnancy test kit. For the purposes ofpresenting a brief and clear description of the present invention, thepreferred embodiment will be discussed as used to detect pregnancy infemale mammals. The figures are intended for representative purposesonly and should not be considered to be limiting in any respect.

Referring now to FIG. 1, there is shown a top down view of the presentinvention. The present invention comprises an at-home blood pregnancytest kit 21. The test kit 21 comprises a substantially rectangularhousing 22 having an upper end 33 with a centrally located opening 34along the length thereof, a lower end 35, a top side, a bottom side, anda hollow interior. In the illustrated embodiment, the opening 34comprises a semi-circular cutout that extends towards the lower end 35.The opening 34 is adapted to provide access to the hollow interior ofthe housing 22. In a preferred embodiment, the housing 22 is composed ofplastic or other suitable materials.

The opening 34 comprises a sample strip 23 held therebetween. The samplestrip 23 comprises a piece of porous paper or sintered polymer that hasthe capacity to transport fluid spontaneously. The sample strip 23comprises a first end and a second end. The first end of the samplestrip 23 protrudes outward from the opening 34 so that the user canreadily access the sample strip 23 and the sample strip 23 can collect ablood sample. It is contemplated that the user can prick her finger anddab the blood on the sample strip 23. The second end of the sample strip23 extends inward into the housing 22 so that the sample strip 23directly contacts a sample pad within the interior of the housing 22 todeliver the blood sample to the sample pad.

The housing 22 also comprises a test window 24. In the illustratedembodiment, the test window 24 comprises a rectangular cutout thatallows the user to view a portion of the test pad, which is disposedwithin the interior of the housing 22. The test pad is adapted todisplay a plus sign 28 for showing a positive pregnancy result, a minussign 27 for showing a negative pregnancy result, and a control indicator26 for showing that the test was performed correctly.

The housing 22 further comprises a push button 25 that comprises ahollow interior for holding a reagent therein. It is contemplated thatthe reagent may be in a form of a solid capsule that can react with anyhCG present in the blood sample. The push button 25 comprises a roundprotrusion that can be pressed towards the back side of the housing 22.When the push button 25 is pressed, the reagent can be crushed into apowder form and remain on the conjugate pad. Accordingly, the conjugatepad is directly subjacent to the push button 25. Alternatively, thereagent may be in a form of a liquid that can be released onto theconjugate pad when the push button 25 is pressed, whereby actuating thebutton 25 can break a seal within the interior of the push button 25 toallow the reagent to escape therefrom.

Referring now to FIG. 2, there is shown a cutout view of the bloodpregnancy test kit 21 of the present invention. In one embodiment, thepresent invention comprises an hCG immunoassay to measure the presenceof hCG in a blood sample. The hCG immunoassay of the present inventionis based on the sandwich principal; comprising a first antibody bindsand immobilizes hCG antigens in the blood sample, and a second antibodyraised to a distant epitope and labeled with a dye. In otherembodiments, however, the distant epitope may be labeled with an enzyme,or chemiluminescence agent, or other suitable substances that can markthe presence of hCG in a blood sample, such that the marking is visibleto an unaided eye. The present invention is designed to primarily detectthe regular placental form of the hCG because regular hCG is consideredto be the key marker for pregnancy.

The sample strip 23 transports blood spontaneously into the sample pad30. In some embodiments, the sample pad 30 may comprise a pad that actsas a sponge and holds an excess of blood sample. Once soaked, the bloodmigrates toward the test pad 29. The push button 25 is actuated torelease the reagent at the conjugate pad 31, which then also travelstowards the test pad 29. In this way, the reagent and the blood samplemeet at the test pad 29. The reagent comprises a conjugate that iscomposed of particles that can chemically react with hCG, wherein thesurface of the particles comprises a first antibody that can bind andimmobilize hCG antigens.

Once the blood has migrated to the test pad 29, the blood can dissolveparticles, so that the blood and the reagent can mix, creating ablood-reagent mixture. In this way, any hCG antigen present in theblood-reagent mixture can bind to the first antibody while migratingthrough the test pad 29. Accordingly, it is contemplated that the samplepad 30, the test pad 29, and the conjugate pad 31 are in fluidcommunication. Additionally, the sample pad 30 is directly adjacent tothe test pad 29, which is also directly adjacent to the conjugate pad31. In this way, the sample pad 30, the test pad 29, and the conjugatepad 31 directly contact one another. The sample pad 30, the test pad 29,and the conjugate pad 31 are coplanar and form a substantiallycontiguous surface when viewed from the side.

The test pad 29 is preferably composed of nitrocellulose, or a similarmembrane. The test pad 29 comprises a test portion 33 and a controlportion 32. Each of the test portion 33 and the control portion 32comprises an indicator. Each indicator may include an antibody that hasbeen immobilized. When the control portion 32 captures the blood-reagentmixture, the indicator of the control portion 32 can change color,thereby showing that reaction conditions and technology were operable,regardless of the presence of hCG. In the exemplary embodiment, thecontrol portion 32 can show a marking such as a square shape when theindicator changes in color. The marking is visible through the testwindow 24. However, the control portion 32 may show other shapes or aline, depending upon embodiment.

The test portion 33 may comprise a second antibody that is labeled witha dye, which can be used to show a minus sign or a plus sign, dependingupon whether hCG is present in the blood sample. When the secondantibody binds with the hCG antigen, which is already bonded to a firstantibody, the dye is actuated to mark the absence of the presence of hCGin the blood sample. If the hCG is absent or the concentration of hCG isunder 5 mlU/ml, then the test will be considered negative, and a minussign is shown. If the level of hCG is determined to be between 5 and 25mlU/ml, then the test will be considered positive, and a plus sign isshown. The plus and minus signs are visible through the test window 24.In alternate embodiments, it is contemplated that the test portion 33 isadapted to change color when the level of hCG is determined to bebetween 5 and 35 mlU/ml.

Though the test window 24 and the test pad 29 is disposed between thesample pad 30 and the conjugate pad 31 in the illustrated embodiment,the test window 24 and the test pad 29 may be disposed at the lower endof the housing 22, depending upon embodiment. Furthermore, and in someembodiments, the present invention may further comprise a wick, whichsimply acts as a waste container for the blood sample.

It is therefore submitted that the instant invention has been shown anddescribed in what is considered to be the most practical and preferredembodiments. It is recognized, however, that departures may be madewithin the scope of the invention and that obvious modifications willoccur to a person skilled in the art. With respect to the abovedescriptions then, it is to be realized that the optimum dimensionalrelationships for the parts of the invention, to include variations insize, materials, shape, form, function, and manner of operation,assembly and use, are deemed readily apparent and obvious to one skilledin the art, and all equivalent relationships to those illustrated in thedrawings and described in the specifications are intended to beencompassed by the present invention.

Therefore, the foregoing is considered as illustrative only of theprinciples of the invention. Further, since numerous modifications andchanges will readily occur to those skilled in the art, it is notdesired to limit the invention to the exact construction and operationshown and described, and accordingly, all suitable modifications andequivalents may be resorted to, falling within the scope of theinvention.

I claim:
 1. An at-home blood pregnancy test kit, comprising: a housinghaving an upper end with an opening and an interior volume having asample pad, a conjugate pad, and a test pad therebetween; a sample stripextending outward from said opening; said sample strip adapted tocollect a blood sample and deliver it to said sample pad; a push buttonadapted to release a reagent at said conjugate pad; wherein said reagentcomprises a first antibody that binds with hCG antigens to detectpresence of hCG in said blood sample; said reagent combining with saidblood sample to create a blood-reagent mixture at said test pad; whereinsaid test pad comprises a second antibody that binds with hCG antigens;wherein said test pad is adapted to indicate presence of hCG in saidblood sample, whereby presence of hCG in said blood sample above apredetermined threshold provides a positive pregnancy test result andpresence of hCG in said blood sample below said predetermined thresholdor absence of hCG in said blood sample provides a negative pregnancytest result.
 2. The at-home blood pregnancy test kit of claim 1, whereinsaid opening is centrally located on said upper end of said housing. 3.The at-home blood pregnancy test kit of claim 1, wherein said samplepad, said conjugate pad, and said test pad are in fluid communication.4. The at-home blood pregnancy test kit of claim 1, wherein saidconjugate pad is directly subjacent to said push button.
 5. The at-homeblood pregnancy test kit of claim 1, wherein said test pad comprises atest portion and a control portion; said control portion adapted todisplay a marking when in direct contact with said blood-reagentmixture; said test portion adapted to display a plus sign when presenceof said hCG in said blood sample exceeds said predetermined threshold;said test portion adapted to display a minus sign when presence of saidhCG in said blood sample is absent or below said predeterminedthreshold.
 6. The at-home blood pregnancy test kit of claim 5, whereinsaid test portion and said control portion are visible through a testwindow on said housing.
 7. The at-home blood pregnancy test kit of claim1, wherein said predetermined threshold is 5 mlU/ml.